Guidewire with an integrated flexible tube

ABSTRACT

An integrated guidewire includes a wire and a flexible tube. The wire is sized and shaped to move in an anatomical material transportation system of a patient. The flexible tube is sized and shaped to move in the anatomical material transportation system, having proximal and distal ends, the proximal-end is coupled to a device external to the patient, the flexible tube is configured to transfer fluids between the distal-end and the device, and the wire and the flexible tube are intertwined with respect to one another.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication 62/718,722, filed Aug. 14, 2018, whose disclosure isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, andparticularly to methods and systems for producing integrated guidewiresand for applying these guidewires in medical procedures.

BACKGROUND OF THE INVENTION

Guidewires are used in various medical applications, such as inneurology, cardiology and sinuplasty.

For example, U.S. Patent Application Publication 2003/0181894 describesa device and method for preventing restenosis and streamlining anangioplasty procedure. The device and method provide a fiber-opticguidewire, or, alternatively, a light-conducting catheter, to decreasethe size of the angioplasty device, decrease the overall time of theprocedure, and increase the safety of the procedure.

U.S. Pat. 5,441,497 describes a light diffusing guidewire which has theability to deliver light to luminal surfaces such as blood vessels forthe diagnosis and treatment of medical conditions. The guidewire has anelongate body portion having a proximal end and a distal (invasive) end.A portion of the body portion transmits light from the proximal end to alight diffusing element within the body portion near the distal end.

U.S. Patent Application Publication 2006/0074442 describes a deflectableand torqueable hollow guidewire device for removing occlusive materialand passing through occlusions and other materials in a body lumen. Thehollow guidewire generally comprises an elongate, tubular guidewire bodythat has an axial lumen. A mechanically moving core element ispositioned at or near a distal end of the tubular guidewire body andextends through the axial lumen.

U.S. Pat. No. 5,372,587 describes a steerable tubular sheath comprisingan elongate flexible tubular body, having a laterally deflectable distaltip. Lateral deflection of the tip is accomplished by axial displacementof at least one pull wire extending through the housing. The housingcomprises at least one central lumen extending axially therethrough, forreceiving medical implements, optical fibers, suction or transmission offluids such as for irrigation or drug delivery.

SUMMARY OF THE INVENTION

An embodiment of the present invention that is described herein providesan integrated guidewire including a wire and an optical fiber. The wireis sized and shaped to move in an anatomical material transportationsystem of a patient. The flexible tube has proximal and distal ends, theproximal-end is coupled to a device external to the patient, theflexible tube is configured to transfer fluids between the distal-endand the device, and the wire and the flexible tube are intertwined withrespect to one another.

In some embodiments, the wire and the flexible tube are fixed directlyto one another at one or more coupling points located between or at thedistal-end and the proximal-end. In other embodiments, the integratedguidewire includes a fluid reservoir configured to supply the fluids toat least one of the device and the flexible tube. In yet otherembodiments, the flexible tube is configured to transfer the fluids forat least one of: (i) irrigating the organ, (ii) treating an infection ora tumor in the organ, and (iii) drawing fluids out of a body of thepatient.

In an embodiment, the intertwined wire and the flexible tube have,between the distal-end and the proximal-end, multiple windings around anaxis of the integrated guidewire. In another embodiment, a number of thewindings sets stiffness and flexibility levels of the integratedguidewire. In yet another embodiment, the windings are distributedevenly between the distal-end and the proximal-end.

In some embodiments, the windings are distributed unevenly between thedistal-end and the proximal-end. In other embodiments, the integratedguidewire includes at least one of an additional flexible tube and anoptical fiber configured to transfer optical signals between thedistal-end and the proximal-end, and the at least one of the additionalflexible tube and the optical fiber is intertwined with the wire and theflexible tube. In yet other embodiments, the anatomical materialtransportation system includes an anatomical system of the patientselected from a list consisting of a vasculature system, anear-nose-throat (ENT) system, and a neurological system.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method including inserting into an anatomicalmaterial transportation system of a patient an integrated guidewire thatincludes (i) a wire, which is sized and shaped to move in the anatomicalmaterial transportation system, and (ii) a flexible tube, sized andshaped to move in the anatomical material transportation system andhaving proximal and distal ends, the proximal-end is coupled to a deviceexternal to the patient, the flexible tube is configured to transferfluids between the distal-end and the device, and the wire and theflexible tube are intertwined with respect to one another. The fluidsare transferred between the distal-end and the device.

There is further provided, in accordance with an embodiment of thepresent invention, a method for producing an integrated guidewire, themethod includes providing a wire which is sized and shaped to move in ananatomical material transportation system of a patient. The wire and aflexible tube are intertwined with respect to one another.

The present invention will be more fully understood from the followingdetailed description of the embodiments thereof, taken together with thedrawings in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic, pictorial illustration of a sinuplasty surgicalsystem, in accordance with an embodiment of the present invention;

FIGS. 2A-2C are schematic, pictorial illustrations of an integratedguidewire, in accordance with an embodiment of the present invention;

FIG. 3 is a flow chart that schematically illustrates a method forapplying an integrated guidewire in medical procedures, in accordancewith an embodiment of the present invention; and

FIG. 4 is a flow chart that schematically illustrates a method forproducing an integrated guidewire, in accordance with an embodiment ofthe present invention.

DETAILED DESCRIPTION OF EMBODIMENTS Overview

Embodiments of the present invention that are described hereinbelowprovide improved methods and systems for producing and applyingintegrated guidewires comprising one or more transferring devices, suchas optical fibers and/or fluid transferring tubes.

In principle, an optical fiber may be integrated in a guidewire usingvarious methods, such as by laser cutting a spiral in a tube (to makethe tube flexible) and feeding a fiber optic through the tube. Inanother possible method, a laser can be applied for cutting a spiralgroove in a wire, wherein the optical fiber in the groove. Thesemethods, however, are costly and difficult to apply in high volumemanufacturing (HVM). Moreover, some medical procedures require drawingfluids out of a narrow lumen of a patient body (e.g., a blood vessel inthe brain), or administering fluids thereto. Such procedures may becarried out using a guidewire, but guidewires with integrated tubes aredifficult to manufacture.

Embodiments of the present invention provide improved techniques forproducing such integrated guidewires by intertwining a wire and at leastone of, (i) an optical fiber and (ii) a flexible tube, with respect toone another.

In some embodiments, an integrated guidewire comprises a wire, which issized and shaped to move in an anatomical material transportation systemof a patient, such as in the vasculature system of the brain, or in anear-nose-throat (ENT) system of the patient. In some embodiments, theintegrated guidewire further comprises one or more transferring devicessuch as an optical fiber and a flexible tube.

The proximal end of a transferring device is typically coupled to adevice that remains external to the patient body, whereas the distal endof the transferring device is inserted into the patient body. In someembodiments, the optical fiber is configured to transfer optical signalsbetween the distal-end and the external device, and the flexible tube isconfigured to transfer fluids and foreign material between thedistal-end and the external device. In an embodiment, the wire and oneor more transferring devices are intertwined with respect to oneanother.

In some embodiments, the flexible tube may be coupled to a reservoir offluid external to the patient body, and configured to transfer the fluidfrom the reservoir to an organ in question. In other embodiments, theflexible tube may be coupled to a pump, which is configured to drawfluids and foreign material out of the patient body.

In an example embodiment, a physician may insert into the patient brain,an integrated guidewire comprising a wire, an optical fiber and aflexible tube, all are intertwined with respect to one another. Thephysician may navigate the integrated guidewire through the brainvasculature to a location that is suspected to be clotted. In thisembodiment, the physician may investigate the clot by bringing theintegrated guidewire in close proximity thereto, and illuminating theclot using the optical fiber. Based on the information collected in theinvestigation, the physician may apply the flexible tube for: (i)drawing the clot out of the patient brain, or (ii) dissolving the clotby administering a substance from the reservoir, or using any othersuitable technique, such as irrigation and/or a combination ofirrigation and suction of the clot out of the patient brain.

In another embodiment, the physician may sequentially apply twointegrated guidewires of different types, e.g., a diagnostics guidewirecomprising the intertwined wire and optical fiber, and a treatmentguidewire comprising the intertwined wire and flexible tube. In thisembodiment, the physician may first apply the diagnostics guidewire soas to investigate the clot, and subsequently retract the diagnosticsguidewire and insert the treatment guidewire for treating the clot asdescribed above.

The disclosed techniques improve the functionality of integratedguidewires to carry out diagnostic and treatment procedures, by enablingthe integration of the wire with at least an optical fiber and/or aflexible tube. Furthermore, these techniques reduce the complexity andtherefore cost of producing such integrated guidewires.

System Description

FIG. 1 is a schematic pictorial illustration of a sinuplasty procedureusing a surgical system 20, in accordance with an embodiment of thepresent invention. In the example of FIG. 1, system 20 comprises acatheter 28, which a physician 24 inserts into a nose 26 of a patient 22so as to treat an ear-nose-throat (ENT) disease, such as infection inone or more sinuses of patient 22. In other embodiments, system 20 maybe used in other medical procedures, such as in diagnosing and treatinga clot in the patient brain or other organ. Additionally oralternatively, system 20 may be used for administrating substances into,or suctioning material out of an organ or an anatomical materialtransportation system of patient 22, or for irrigating the organ or theanatomical material transportation system of patient 22.

Reference is now made to an inset 40 that shows a frontal anatomicalview of the ENT system of patient 22. The ENT system of patient 22comprises a frontal sinus 42 and a maxillary sinus 46. Ostia 44 and 48connect between cavities of the nose (not shown) and sinuses 42 and 46,respectively. Catheter 28 comprises an integrated guidewire 29 having adistal end 38. In the context of the present invention the term“integrated guidewire” is also referred to below simply as “guidewire”for brevity. In an embodiment, the tip of distal end 38 may comprise aposition sensor 56 attached at the end of a residual end section 55 ofguidewire 29.

Catheter 28 further comprises an inflatable balloon 50, which may beconfigured in two positions, e.g., an expanded (inflated) position and acollapsed position. When Balloon 50 is in the collapsed position, thecatheter can be navigated to the target location. The balloon is theninflated to the expanded position using a suitable fluid (e.g., a salinesolution so as to anchor catheter 28 at the target location (e.g.,ostium 44) in the ENT system of patient 22.

Catheter 28 further comprises a handle 30, which is located at theproximal end of catheter 28. Handle 30 is configured to control thenavigation of guidewire 29 and the motion of balloon 50 along guidewire29.

In some embodiments, system 20 further comprises a location pad 60placed at a known position external to patient 22 lying on table 31, pad60 comprises field-generators 64 fixed on a frame 66. In the exemplaryconfiguration shown in FIG. 1, pad 60 comprises five field-generators64, but may alternatively comprise any other suitable number offield-generators 64. Pad 60 further comprises a pillow (not shown)placed under a head 41 of patient 22, such that field-generators 64 arelocated at fixed, known positions external to head 41.

In some embodiments, system 20 comprises a console 33, which comprises adriver circuit 62 configured to drive, via a cable 37, field-generators64 with suitable signals so as to generate magnetic fields in apredefined working volume in space around head 41. In some embodiments,console 33 comprises a processor 34, typically a general-purposecomputer, with suitable front end and interface circuits for receiving,via a cable 32, signals from catheter 28. Console 33 further comprisesinput devices 39 and a display 36, which is configured to display data(e.g., images) received from processor 34 or inputs inserted by a user(e.g., physician 24). In an embodiment, the position of position sensor56 is typically measured by magnetic position sensing of a catheterposition tracking system comprised in system 20.

This method of position sensing is implemented in various medicalapplications, for example, in the CARTO™ system, produced by BiosenseWebster Inc. (Irvine, Calif.) and is described in detail in U.S. Pat.Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and6,332,089, in PCT Patent Publication WO 96/05768, and in U.S. PatentApplication Publications 2002/0065455 A1, 2003/0120150 A1 and2004/0068178 A1, whose disclosures are all incorporated herein byreference.

In some embodiments, system 20 may comprise an optical module,comprising a light source (not shown) that may be disposed in a suitabledevice of systems 20, such as in console 33 or in handle 30, and animage sensor (not shown) that may be mounted on distal end 38. In someembodiments, the light source and image sensor are optically coupled toone another via a light transferring device, such as an optical fiber,shown in FIGS. 2A, 2B and 2C below.

In other embodiments, system 20 may comprise a fluid distributionmodule, which comprises a fluid reservoir (not shown) filled with afluid for medical use, such as irrigation fluid for irrigating an organ,or some substance for treating an infection or a tumor in an organ ofpatient 22. The reservoir may be disposed in any suitable device ofsystems 20, such as in console 33 or in handle 30, or in a separate tankof fluids.

In an embodiment, the fluids may be transferred from the reservoir todistal end 38 via a fluid transferring device, such as a flexible tube,shown in FIGS. 2A, 2B and 2C below, and disposed to a target organthrough fluid distribution holes (not shown) formed in distal end 38. Insome embodiments, the fluid transferring device may comprise a flexibleirrigation tube having one or more openings, e.g., irrigation holes (notshown). The flexible irrigation tube is configured to transfer, via theirrigation holes, irrigation fluid from the reservoir to an organ inquestion. In other embodiments, the fluid transferring device isconfigured to transfer a liquid substance, such as a drug, for treatinginfection or a tumor in the organ in question.

In alternative embodiments, system 20 may comprise a material evacuationmodule (not shown) comprising a suction pump (not shown), which isconfigured to pump materials out of an organ of patient 22, via thefluid transferring device, e.g., into a sink (not shown) locatedexternal to patient 22.

During the sinuplasty procedure, physician 24 navigates the tip ofguidewire 29 into sinus 42. In some cases, e.g., when treating infectionin the sinus, it is important for the physician to anchor the distal tipof the catheter, for example by inflating balloon 50 in ostium 44. In anembodiment, balloon 50 may be 16 mm long and may have a diameter of 5mm, such as sinuplasty balloon produced by Acclarent Inc. (catalognumber RSP0516MFS), yet any other suitable balloon with other dimensionsmay be used in the disclosed techniques.

After inserting distal end 38 into the ENT system, physician 36navigates balloon 50 to ostium 44. Note that, typically, balloon 50 doesnot comprise a position sensor and is not otherwise imaged on display36. To perform the treatment safely and efficiently, it is important toposition balloon 50 accurately within ostium 44. For example,positioning balloon 50 in the nose cavity, short of ostium 44, may notallow the physician to anchor end section 55 within sinus 42, whereaspositioning the balloon within sinus 42, deeper than ostium 44, maydisturb the physician in treating the infection therein.

In the example of FIG. 1, balloon 50 is used for anchoring end section55 within sinus 42. In alternative embodiments, any other suitabledevice may be positioned using the disclosed techniques, instead ofballoon 50. Such a device may comprise, for example, an alternativeanchoring device for anchoring the end section or for any otherdiagnostic or treatment purpose. For example, a balloon may be used fortreating cardiac arrhythmia at a pulmonary vein (PV) in a PV isolationprocedure. In other applications, a drug dispensing device or a stentmay be navigated to a specific location in a human organ, using thetechniques described above.

In some embodiments, processor 34 is configured to assist physician 24to position balloon 50 accurately within ostium 44. FIG. 1 shows onlyelements related to the disclosed techniques, for the sake of simplicityand clarity. System 20 typically comprises additional modules andelements that are not directly related to the disclosed techniques, andthus, intentionally omitted from FIG. 1 and from the correspondingdescription.

Processor 34 may be programmed in software to carry out the functionsthat are used by the system, and to store data in a memory (not shown)to be processed or otherwise used by the software. The software may bedownloaded to the processor in electronic form, over a network, forexample, or it may, alternatively or additionally, be provided onnon-transitory tangible media, such as optical, magnetic or electronicmemory media. Alternatively, some or all of the functions of processor34 may be carried out by dedicated or programmable digital hardwarecomponents.

In some embodiments, catheter 28 and guidewire 29 may be used inapplying medical procedures to various human anatomical systems, such asbut not limited to the vasculature system, ENT system, neurologicalsystem and patient heart. In an example embodiment, guidewire 29 maycomprise an optical fiber (shown in FIG. 2 below) that may be used forilluminating the inner lumen of the blood vessels in the brain ofpatient 22 so as to investigate a clot in the brain or a tear in a bloodvessel, or for any other diagnostics or treatment purpose in any organor material transportation system of patient 22, as will be described indetail below. In another exemplary embodiment, guidewire 29 may comprisea flexible tube (shown in FIG. 2 below) that may be used for irrigatingan organ of patient 22 (e.g., for cooling the organ during ablation), orfor administering a substance into an organ of patient 22 (e.g., fortreating infection or a tumor), or for suctioning some material to beremoved out of an organ of the patient.

Integrated Guidewire Comprising an Optical Fiber and/or a Flexible Tube

FIG. 2A is a schematic, pictorial illustration of an integratedguidewire 65, in accordance with an embodiment of the present invention.Guidewire 65 may replace, for example, guidewire 29 of FIG. 1 above. Insome embodiments, guidewire 65 comprises a wire 70, which is sized andshaped to move in an anatomical material transportation system ofpatient 22. The transportation system may comprise ostia 44 and 48 andsinuses 42 and 46 of the ENT system shown in the example of FIG. 1, orblood vessels connecting between the heart (not shown) and any organ ofpatient 22, such as the brain.

In some embodiments, wire 70 is made from any suitable biocompatiblematerial, such as an alloy of nickel-titanium, stainless steel,titanium, nickel, or from gold, or platinum. In other embodiments, wire70 is made from two or more parts, one of which comprises a core, madefrom any suitable material, coated with a biocompatible material.

In some embodiments, guidewire 65 comprises a transferring device 72having a proximal end 73 and a distal end 71, such that wire 70 andtransferring device 72 are intertwined with respect to one another. Inthe configuration of FIG. 2A, wire 70 is laid out straight and alignedwith a longitudinal axis 78 of guidewire 65, whereas transferring device72 is wound around axis 78 and is coupled to an outer surface of wire70. In some embodiments, transferring device 72 may comprise an opticalfiber which is coupled to a light source (not shown), and is configuredto transfer optical signals between the light source and distal end 71.

In an example embodiment, physician 24 may apply handle 30 for movingguidewire 65 in a blood vessel of the patient brain so as to bringdistal end 71 adjacent to a clot in the brain. In this embodiment, theoptical fiber transfers light from the light source toward the distalend so as to illuminate a section of the brain and the clot, and furthertransfers light that is reflected by the brain and clot back to theimage sensor at the proximal end as described in FIG. 1 above, so as toacquire anatomical information on the clot and the brain section.

In another embodiment, transferring device 72 may comprise a flexibletube, which is coupled to the fluid reservoir described in FIG. 1 above,and is configured to transfer fluids between the reservoir and distalend 71. In an embodiment, transferring the fluid may be used forirrigating an organ, for example, during an ablation procedure.Alternatively, the flexible tube may be used for administeringmedication from the reservoir to an organ of patient 22, for treatingthe infection or tumor as described above.

In alternative embodiments, transferring device 72 may comprise theflexible tube described above, which is coupled to a pump and configuredto draw material, such as infection or any undesired material, from thebody of patient 22. In these embodiments, distal end 71 of the flexibletube is disposed in the organ in question, and proximal end 73 iscoupled to the pump and sink described in FIG. 1 above.

In some embodiments, during the production of integrated guidewire 65,transferring device 72 is wound around wire 70, thereby forming multiplewindings, such as windings 74 and 76 having a predefined pitch size. Itwill be understood that the pitch size and the number of windings may bevaried so as to obtain a desired tradeoff between flexibility andstiffness of integrated guidewire 65. In the example embodiment of FIG.2A, integrated guidewire 65 comprises eight windings of transferringdevice 72 around wire 70. In another embodiment, the guidewire maycomprise only five windings, resulting in lower stiffness and higherflexibility compared to the example embodiment of FIG. 2A. In otherwords, a smaller pitch size results in higher stiffness and lowerflexibility of the integrated guidewire.

Note that the pitch size may be uniform, or may vary, along theintegrated guidewire, so as to obtain different levels of stiffness andflexibility along the integrated guidewire.

In some embodiments, transferring device 72 and wire 70 are cemented toone another at selected locations along integrated guidewire 65,typically including distal end 71 and proximal end 73. For example,transferring device 72 and wire 70 may be coupled to one another atleast at one coupling point located between distal-end 71 andproximal-end 73. In the context of the present invention, the term“cemented” refers to coupling between transferring device 72 and wire 70using any suitable coupling technique, such as gluing or soldering. Insome embodiments, the materials used for cementing between device 72 andwire 70 are typically biocompatible, or coated with a biomaterial afterthe cementing process.

The various configurations of integrated guidewire 65 are depictedpurely by way of example. In alternative embodiments, guidewire 65 maycomprise any suitable number and types of transferring devices woundaround wire 70 in any suitable winding configuration. For example,integrated guidewire 65 may comprise two or more transferring devicesintertwined around axis 78, on the outer surface of wire 70.

FIG. 2B is a schematic, pictorial illustration of an integratedguidewire 75, in accordance with another embodiment of the presentinvention. Guidewire 75 may replace, for example, guidewire 29 of FIG. 1above. In some embodiments, integrated guidewire 75 comprises a wire 80having similar properties to wire 70 of FIG. 2A, and a transferringdevice 82 having a proximal end 83 and a distal end 81, such that wire80 and transferring device 82 are intertwined with respect to oneanother.

In the configuration of FIG. 2B, transferring device 82 is laid outstraight and aligned with a longitudinal axis 88 of guidewire 75,whereas wire 80 is wound around axis 88 and is coupled to an outersurface of transferring device 82.

In some embodiments, transferring device 82 may comprise an opticalfiber which is coupled to the light source (not shown), described inFIG. 1 above, and is configured to transfer optical signals between thelight source and distal end 81, as also described in FIG. 2A above.

In another embodiment, transferring device 82 may comprise a flexibletube, which is coupled to the fluid reservoir described in FIG. 1 above.In the form of the flexible tube, transferring device 82 is configuredto transfer fluids, such as irrigation fluids or medication substance,between the reservoir and distal end 81, as described in FIG. 2A above.

In alternative embodiments, transferring device 82 may comprise aflexible tube, which is coupled to a pump and configured to drawmaterial, such as infection or any undesired material, from the body ofpatient 22. In these embodiments, distal end 81 of the flexible tube isdisposed in the organ in question, and proximal end 83 is coupled to thepump and sink described in FIG. 1 above.

In some embodiments, during the production of integrated guidewire 75,wire 80 is wound around transferring device 82, thereby forming multiplewindings, such as windings 84 and 86 having an even or a variable pitchsize. In these embodiments, the windings are distributed evenly alongintegrated guidewire 75, between distal end 81 and proximal end 83. Asdescribed in FIG. 2A above, the pitch size and the number of windingsmay vary along axis 88 so as to determine the flexibility and stiffnessof each section of integrated guidewire 75.

In some embodiments, transferring device 82 and wire 80 are cemented toone another, using the techniques described in FIG. 2A above.

FIG. 2C is a schematic, pictorial illustration of an integratedguidewire 85, in accordance with another embodiment of the presentinvention. Guidewire 85 may replace, for example, guidewire 29 of FIG. 1above. In some embodiments, integrated guidewire 85 comprises a wire 90having similar properties to wire 70 of FIG. 2A, and a transferringdevice 92 having a proximal end 93 and a distal end 91.

During the production of integrated guidewire 85, transferring device 92and wire 90 are intertwined with respect to one another as in a twistedpair configuration, and subsequently, are cemented to one another, usingthe cementing techniques described in FIG. 2A above.

In some embodiments, during the production of guidewire 85, transferringdevice 92 and wire 90 are coupled to one another, permanently ortemporarily, at one end (e.g., at proximal end 93). Subsequently, device92 and wire 90 are braided relative to one another around a longitudinalaxis 98 of guidewire 85, such that neither wire 90 nor transferringdevice 92 are laid out straight.

After shaping guidewire 85 as a braid, device 92 and wire 90 may bepermanently coupled to one another, typically at the distal and proximalends, using the techniques described in FIG. 2A above.

In the example of FIG. 2C, integrated guidewire 85 has a uniform pitch94 substantially smaller than pitch 84 of guidewire 75, resulting inthirteen windings per 5 mm of linear length in guidewire 85 compared toeight windings per 5 mm in guidewire 75. As a result, guidewire 85 hashigher stiffness and lower flexibility compared to guidewire 75,assuming wires 80 and 90 are substantially identical, and usingsubstantially identical transferring devices 82 and 92. Note that inother configurations the size of pitch 94 may vary along axis 98 ofguidewire 85, so as to obtain the desired stiffness and flexibility aseach section of integrated guidewire 85. In case increased stiffness isdesired, the twisted pair of wire 90 and transferring device 92 may befixed directly together using any suitable fixation technique, e.g.,epoxy, polyurethane, staples or crimping bands.

In some embodiments, transferring device 92 may comprise an opticalfiber which is coupled to the light source (not shown), described inFIG. 1 above, and is configured to transfer optical signals between thelight source and distal end 91, as also described in FIG. 2A above.

In another embodiment, transferring device 92 may comprise a flexibletube, which is coupled to the fluid reservoir described in FIG. 1 above.In the form of the flexible tube, transferring device 92 is configuredto transfer fluids, such as irrigation fluids or medication substance,between the reservoir and distal end 91, as described in FIG. 2A above.

In alternative embodiments, transferring device 92 may comprise aflexible tube, which is coupled to a pump and configured to drawmaterial, such as infection or any undesired material, from the body ofpatient 22. In these embodiments, distal end 91 of the flexible tube isdisposed in the organ in question, and proximal end 93 is coupled to thepump and sink described in FIG. 1 above.

The particular configurations of integrated guidewires 65, 75 and 85 areshown by way of example, in order to illustrate certain problems thatare addressed by embodiments of the present invention and to demonstratethe application of these embodiments in enhancing the performance of amedical system such as system 20.

Embodiments of the present invention, however, are by no means limitedto this specific sort of example integrated guidewires, and theprinciples described herein may similarly be applied to other sorts ofintegrated guidewires. In an alternative embodiment, another type ofintegrated guidewire may comprise two or more transferring devices. Inan example embodiment, the guidewire may comprise a single wire and twoflexible tube, a first tube for pumping fluids to the organ in questionand a second tube for drawing material out of the patient body. The wireand the flexible tubes may be wound around the longitudinal axis of theintegrated guidewire, using any suitable winding technique, such as thetechniques described in FIGS. 2A-2C above. This configuration may beused to remove undesired material from patient body using a flux ofincoming fluid from the first tube and using the second tube for drawinga mixture of the undesired material and the incoming fluid. Inalternative embodiments, the integrated guidewire may comprise anoptical fiber and a suction tube, for example, so as to investigate theclot in the brain, and if medically applicable, to draw the clot out ofthe brain thereafter, using the suction tube.

In other embodiments, the integrated guidewire may comprise anycombination of one or more wires, wound around an axis with one or moreoptical fibers, and/or one or more flexible tubes, and/or any other oneor more suitable types of transferring devices.

FIG. 3 is a flow chart that schematically illustrates a method forapplying integrated guidewire 75 in various medical procedures, inaccordance with an embodiment of the present invention. Note thatintegrated guidewire 75 was selected purely by way of example. Inalternative embodiments, any other suitable type of integratedguidewire, such as guidewires 65 and 85 depicted above, may be appliedin addition to, or instead of guidewire 75.

The method begins at a guidewire insertion step 100, with physician 24inserting integrated guidewire 75 into an anatomical materialtransportation system of patient 22. As described in FIG. 2B above,guidewire 75 comprises wire 80 intertwined with transferring device 82,such as the optical fiber or the flexible tube.

At a navigation step 102, physician 24 navigates integrated guidewire 75to an organ in question, such as the brain or frontal sinus 42 ofpatient 22. At a first decision step 104, physician 24 checks whetherinvestigation of a potential clot in the brain of patient 22 isrequired.

When at step 104 physician 24 decides to investigate the potential clotand assuming guidewire 75 comprises the optical fiber, physician 24 mayapply guidewire 75 to acquire anatomical information, such as images ofthe clot, at an anatomical image acquisition step 106. After concludingthe acquisition of clot images, physician 24 may retract guidewire 75out of the body of patient 22, at a guidewire retraction step 118.

At a second decision step 108, physician 24 checks whether irrigation ofan organ of patient 22 is required, for example, to open a block atostium 44 of the ENT system. When at step 108 the physician decides thatirrigation is required, physician 24 may apply guidewire 75 to irrigateostium 44, at an irrigation step 110.

After irrigating ostium 44, physician 24 may retract guidewire 75 out ofthe body of patient 22, at guidewire retraction step 118.

At a third decision step 112, in an embodiment, physician may identifyan infection in frontal sinus 42 and has to decide whether to administera suitable substance, such as an antibiotic drug, for treating theinfection. In another embodiment, based on the images acquired at step106, physician 24 may consider to dissolve the clot in the brain ofpatient 22. At a substance administration step 114, physician may applyguidewire 75 to administrate the substance into the organ in question ofpatient 22. For example, by administering the antibiotic drug intofrontal sinus 42, or by administering a material adapted to dissolve theclot in the brain of patient 22.

After concluding substance administration step 114, physician 24 mayretract guidewire 75 out of the body of patient 22, at guidewireretraction step 118.

At an alternative procedure step 116, physician 24 may decide to treatthe infection in frontal sinus 42 and/or the clot in the brain ofpatient 22 using alternative techniques to substance administration. Forexample, physician 24 may apply guidewire 75 having the suction tubedescribed, for example, in FIG. 2A above. In this embodiment, physician24 may apply the suction tube of guidewire 75 to draw the infection fromsinus 42 and/or to draw the clot from the brain of patient 22.

After concluding the material drawing at step 116, physician 24 mayretract guidewire 75 out of the body of patient 22, at guidewireretraction step 118.

In some embodiments, the procedures described at steps 106, 110, 114 and116 may be carried out separately, such that retraction step 118concludes the method for each procedure. In other embodiments, two ormore of steps 106, 110, 114 and 116 may be carried out sequentially orsimultaneously without retracting guidewire 75 between the respectivesteps. For example, as described above, any integrated guidewire, suchas guidewire 75, may comprise two transferring devices 82, such as anoptical fiber and a suction tube. In these embodiments, physician mayapply the optical fiber to investigate the clot, as described at step106 above, subsequently apply the suction tube so as to draw the clotout of the brain of patient 22, and only then retract guidewire 75 out.

FIG. 4 is a flow chart that schematically illustrates a method forproducing integrated guidewire 65, in accordance with an embodiment ofthe present invention. Note that integrated guidewire 65 was selectedpurely by way of example. In alternative embodiments, any other suitabletype of integrated guidewire, such as guidewires 75 and 85 depictedabove, may be produced in addition to, or instead of guidewire 65.

The method begins with providing wire 70, which is sized and shaped tomove in the blood vessels or in any other anatomical materialtransportation system of patient 22, at a wire provision step 200. Notethat wire 70 may alternatively be produced, for example, by cutting andshaping a section from a continuous wire. At an intertwining step 202, aproduction operator forms integrated guidewire 65 by intertwiningbetween wire 70 and one or more transferring devices 72, which compriseone or more optical fibers and/or one or more flexible tubes asdescribed above.

At a coupling step 202, which concludes the production method ofintegrated guidewire 65, a production operator couples the proximal endof the integrated guidewire to a medical device or system locatedexternally to the body of patient 22. As described above, the medicaldevices or systems may comprise at least one of handle 30, console 33, afluid reservoir, a pump, a light source, an image sensor, and any othersuitable device, apparatus and/or system.

Although the embodiments described herein mainly address sinuplastyprocedures, the methods and systems described herein can also be used inother applications, such as in neurology, cardiology and the vasculaturesystem.

It will thus be appreciated that the embodiments described above arecited by way of example, and that the present invention is not limitedto what has been particularly shown and described hereinabove. Rather,the scope of the present invention includes both combinations andsub-combinations of the various features described hereinabove, as wellas variations and modifications thereof which would occur to personsskilled in the art upon reading the foregoing description and which arenot disclosed in the prior art. Documents incorporated by reference inthe present patent application are to be considered an integral part ofthe application except that to the extent any terms are defined in theseincorporated documents in a manner that conflicts with the definitionsmade explicitly or implicitly in the present specification, only thedefinitions in the present specification should be considered.

1. An integrated guidewire, comprising: a wire, which is sized andshaped to move in an anatomical material transportation system of apatient; and a flexible tube, sized and shaped to move in the anatomicalmaterial transportation system, having proximal and distal ends, whereinthe proximal-end is coupled to a device external to the patient, whereinthe flexible tube is configured to transfer fluids between thedistal-end and the device, and wherein the wire and the flexible tubeare intertwined with respect to one another.
 2. The integrated guidewireaccording to claim 1, wherein the wire and the flexible tube are fixeddirectly to one another at one or more coupling points located betweenor at the distal-end and the proximal-end.
 3. The integrated guidewireaccording to claim 1, and comprising a fluid reservoir configured tosupply the fluids to at least one of the device and the flexible tube.4. The integrated guidewire according to claim 1, wherein the flexibletube is configured to transfer the fluids for at least one of: (i)irrigating the organ, (ii) treating an infection or a tumor in theorgan, and (iii) drawing fluids out of a body of the patient.
 5. Theintegrated guidewire according to claim 1, wherein the intertwined wireand the flexible tube have, between the distal-end and the proximal-end,multiple windings around an axis of the integrated guidewire.
 6. Theintegrated guidewire according to claim 5, wherein a number of thewindings sets stiffness and flexibility levels of the integratedguidewire.
 7. The integrated guidewire according to claim 5, wherein thewindings are distributed evenly between the distal-end and theproximal-end.
 8. The integrated guidewire according to claim 5, whereinthe windings are distributed unevenly between the distal-end and theproximal-end.
 9. The integrated guidewire according to claim 1, andcomprising at least one of an additional flexible tube and an opticalfiber configured to transfer optical signals between the distal-end andthe proximal-end, and wherein the at least one of the additionalflexible tube and the optical fiber is intertwined with the wire and theflexible tube.
 10. The integrated guidewire according to claim 1,wherein the anatomical material transportation system comprises ananatomical system of the patient selected from a list consisting of avasculature system, an ear-nose-throat (ENT) system, and a neurologicalsystem.
 11. A method, comprising: inserting into an anatomical materialtransportation system of a patient an integrated guidewire comprising: awire, which is sized and shaped to move in the anatomical materialtransportation system; and a flexible tube, sized and shaped to move inthe anatomical material transportation system, and having proximal anddistal ends, wherein the proximal-end is coupled to a device external tothe patient, wherein the flexible tube is configured to transfer fluidsbetween the distal-end and the device, and wherein the wire and theflexible tube are intertwined with respect to one another; andtransferring the fluids between the distal-end and the device.
 12. Themethod according to claim 11, wherein the wire and the flexible tube arefixed directly to one another at one or more coupling points locatedbetween or at the distal-end and the proximal-end.
 13. The methodaccording to claim 11, wherein transferring the fluids comprisestransferring the fluids for at least one of: (i) irrigating the organ,(ii) treating an infection or a tumor in the organ, and (iii) drawingfluids out of a body of the patient.
 14. The method according to claim11, wherein the intertwined wire and the flexible tube have, between thedistal-end and the proximal-end, multiple windings around an axis of theintegrated guidewire.
 15. The method according to claim 14, wherein anumber of the windings sets stiffness and flexibility levels of theintegrated guidewire.
 16. The method according to claim 14, wherein thewindings are distributed evenly between the distal-end and theproximal-end.
 17. The method according to claim 14, wherein the windingsare distributed unevenly between the distal-end and the proximal-end.18. The method according to claim 11, wherein inserting the integratedguidewire comprises inserting at least one of an additional flexibletube and an optical fiber for transferring optical signals between thedistal-end and the proximal-end, and wherein the at least one of theadditional flexible tube and the optical fiber are intertwined with thewire and the optical fiber.
 19. The method according to claim 11,wherein inserting the integrated guidewire comprises inserting theintegrated guidewire into an anatomical system of the patient selectedfrom a list consisting of a vasculature system, an ear-nose-throat (ENT)system, and a neurological system.
 20. The method according to claim 11,wherein transferring the fluids comprises drawing fluids from thepatient to the device.
 21. The method according to claim 11, andcomprising drawing fluids and foreign material out of a body of thepatient.
 22. A method for producing an integrated guidewire, the methodcomprising: providing a wire which is sized and shaped to move in ananatomical material transportation system of a patient; and intertwiningthe wire and a flexible tube with respect to one another.
 23. The methodaccording to claim 22, wherein intertwining the wire and the flexibletube comprises coupling the wire and the optical fiber to one another atone or more coupling points located between or at a distal-end and aproximal-end of the optical fiber.
 24. The method according to claim 22,and comprising coupling, to at least one of the device and the flexibletube, a fluid reservoir for supplying the fluids thereto.
 25. The methodaccording to claim 22, wherein intertwining the wire and the flexibletube comprises forming, between a distal-end and a proximal-end of theflexible tube, multiple windings around an axis of the integratedguidewire.
 26. The method according to claim 25, wherein forming themultiple windings comprises setting, by a number of the windings,stiffness and flexibility levels of the integrated guidewire.
 27. Themethod according to claim 25, wherein forming the multiple windingscomprises distributing the windings evenly between the distal-end andthe proximal-end.
 28. The method according to claim 25, wherein formingthe multiple windings comprises distributing the windings unevenlybetween the distal-end and the proximal-end.
 29. The method according toclaim 22, wherein intertwining the wire and the flexible tube comprisesintertwining, with the wire and the optical fiber, at least one of anadditional flexible tube and an optical fiber.
 30. The method accordingto claim 22, wherein the wire is sized and shaped to move in ananatomical system of the patient selected from a list consisting of avasculature system, an ear-nose-throat (ENT) system, and a neurologicalsystem.